Treatment of corneal injury from chemical, radiation, or thermal burns or penetration of foreign bodies.acdefgh

Bacterial Ophthalmic Infections

Used for anti-inflammatory properties in conjunction with appropriate anti-infective therapy in some bacterial infections of the eye;efgh used in fixed combination with neomycin and polymyxin B sulfates or tobramycin when such combination therapy is indicated.efgh If an ophthalmic corticosteroid is used in combination with an ophthalmic anti-infective, weigh benefits against risks.d (See Infections under Cautions.)

Otic Administration

Apply topically to the ear as an otic suspension or an ophthalmic solution.bci

Not for injection.i Do not instill otic preparations into the eye.i

May use dexamethasone sodium phosphate ophthalmic solution in the ear.bc

Shake suspension well prior to each use.i

To avoid dizziness that may result from instilling a cold preparation into the ear, warm the preparation by holding the bottle in the hands for 1–2 minutes prior to administration.i

Clean and dry ear canal prior to administration;bcd pH of otic preparations should be neutral or acidic.b

Lie with the affected ear upward and instill drops.i For pediatric patients with otitis media and tympanostomy tubes, pump the tragus 5 times to ease penetration of drops into the middle ear.i For acute otitis externa, pull outer ear lobe upward and backward to facilitate entry of drug into ear canal.i

Use otic corticosteroids sparingly to prevent an accumulation of excess debris in the ear canal.bd

Dosage

Commercially available alone or in fixed combination with anti-infectives; available as dexamethasone or dexamethasone sodium phosphate.acdefghi Solution available as dexamethasone sodium phosphate; dosage expressed in terms of dexamethasone phosphate.c

Pediatric Patients

Bacterial Ophthalmic Infections

Duration of therapy depends on the type and severity of the disease and response to therapy.g Do not discontinue prematurely.g

When discontinuing therapy, gradually taper dosing frequency to avoid exacerbation of the disease.b

Dexamethasone 0.1% and Tobramycin 0.3%

Ophthalmic Suspension

Children ≥2 years of age: Initial 24–48 hours, 1 or 2 drop(s) into the conjunctival sac of the affected eye(s) every 2 hours.g Thereafter, 1 or 2 drops every 4–6 hours.g Gradually reduce dosing frequency as infection improves.g

Ophthalmic Ointment

Children ≥2 years of age: Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.h

Bacterial Otic Infections

Acute Otitis Externa

Otic Suspension (Dexamethasone 0.1% and Ciprofloxacin 0.3%)

Children ≥6 months of age: 4 drops into the affected ear(s) twice daily for 7 days.i

Acute Otitis Media

Otic Suspension (Dexamethasone 0.1% and Ciprofloxacin 0.3%)

Children ≥6 months of age with tympanostomy tubes: 4 drops into the affected ear(s) twice daily for 7 days.i

Adults

Ophthalmic Inflammation and Bacterial Infections

Duration of therapy depends on the type and severity of the disease and response to therapy.g Do not discontinue prematurely.g

When discontinuing therapy, gradually taper dosing frequency to avoid exacerbation of the disease.b

Dexamethasone 0.1%

Ophthalmic Suspension

For mild inflammation: 1 or 2 drops into the conjunctival sac of the affected eye(s) up to 4–6 times daily.a

For severe inflammation: 1 or 2 drops into the conjunctival sac of the affected eye(s) every hour.a Taper dosing frequency as inflammation subsides.a

Dexamethasone Sodium Phosphate 0.1%

Ophthalmic Solution

Initially, 1 or 2 drops into the conjunctival sac of the affected eye(s) every hour during the day and every 2 hours during the night.c When a favorable response is attained, decrease to 1 drop every 4 hours.c May decrease to 1 drop 3 or 4 times daily to control symptoms.c

Apply a 1.25-cm ribbon into the conjunctival sac of the affected eye(s) up to 3 or 4 times daily.h

Otic Inflammation

Dexamethasone Sodium Phosphate 0.1% Ophthalmic Solution

Otic

Initially, 3 or 4 drops of the ophthalmic solution into the ear canal 2 or 3 times daily.bc May reduce dosing frequency as symptoms improve.bc Gradually taper the drug when it is discontinued.c

Alternatively, a cotton wick saturated with the ophthalmic solution may be packed into the ear canal; keep the wick moist with the ophthalmic solution; remove saturated wick from ear after 12 to 24 hours.bc Repeat as necessary.bc

Duration of treatment may range from a few days to several weeks.b

Bacterial Otic Infections: Acute Otitis Externa

Dexamethasone 0.1% and Ciprofloxacin 0.3%

Otic

4 drops into the affected ear(s) twice daily for 7 days.i

Special Populations

No special population dosage recommendations at this time.acefghi

Cautions for Dexamethasone Sodium Phosphate

Contraindications

Known hypersensitivity to dexamethasone or any ingredient in the formulation.acefghi

Warnings/Precautions

Warnings

Ocular Effects

Risk of glaucoma with possible damage to the optic nerve, defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.acdefgh Use with caution in patients with glaucoma because IOP may increase.acdefgh

If used for ≥10 days, monitor IOP routinely even though monitoring may be difficult in children and uncooperative patients.acdefgh

In conditions causing thinning of the cornea or sclera, perforations reported with use of topical corticosteroids.acdefgh

Use of high-dose corticosteroids may delay healing.ch Use after cataract surgery may delay healing and increase incidence of bleb formation.c

Infections

Prolonged use may suppress the host response and thus increase the risk of secondary ocular infections.acefg

In acute purulent conditions of the eye or ear, corticosteroids may mask infection or enhance existing infection.acdefgh (See Contraindications under Cautions.)

Herpes Simplex

Use of corticosteroids in the treatment of herpes simplex infections other than epithelial herpes simplex keratitis, in which corticosteroids are contraindicated, requires great caution; periodic slit-lamp microscopy is essential.acef

General Precautions

Evaluation of Ocular Condition

Initial prescription or renewal of medication order beyond 8 g of 0.1% ointment or 20 mL of 0.1% suspension should be provided only after examination of the patient with the aid of magnification (e.g., slit lamp biomicroscopy, fluorescein staining where appropriate).efgh

Fungal Infections

Long-term local corticosteroid application associated with development of fungal infections of the cornea.adefgh Consider possibility of fungal infection in patients with persistent corneal ulceration who have been or are receiving corticosteroid therapy.acdefh

Corneal Reepithelialization

Use of ophthalmic ointments may decrease rate of corneal reepithelialization.h

Use of Fixed Combination

When used in fixed combination with ciprofloxacin, neomycin and polymyxin B sulfates, or tobramycin, consider the cautions, precautions, and contraindications associated with the concomitant agents.efghi

Specific Populations

Pregnancy

Category C.acefghi

Lactation

Not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.aefghi

Advice to Patients

Importance of removing soft contact lenses prior to administering preparations containing benzalkonium chlorideagh and of delaying reinsertion of the lenses for ≥15 minutes after administration.c Importance of not wearing contact lenses if signs or symptoms of an eye infection occur.e

Importance of learning and adhering to proper administration techniques to avoid contamination of the tip of the container.aefi

Importance of advising patients not to touch tip of dropper to eye or surrounding tissue.acfghi